Focused Ultrasound for the Treatment of Pancreatic Cancer - an International Registry

Pancreatic Cancer Clinical Trial

— ARRAY  

Official title:

ARRAY: Focused Ultrasound for the Treatment of PAncReatic CanceR - an InternAtional RegistrY

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03724435
• Other study ID #: FUSREG001
• Status: Terminated
• Start date: December 6, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: Focused Ultrasound Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (FUS) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.

Description:

The purpose of the registry is to collect data on the performance of the focused ultrasound (FUS) technology and health outcomes. A wide variety of approaches exist for using FUS on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. This information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. After obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. Patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions. Enrollment Goal: 100 Primary Outcomes: Pain related to pancreatic cancer, Objective response, Progression-free and overall survival, Performance Status, Clinical Benefit Response (CBR), Health-related quality of life

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all registry procedures and availability for the duration of the registry
• Histology proven pancreatic carcinoma in any area of pancreas
• Pancreatic tumor that can be treated by FUS
• Willingness and ability to complete follow-up interviews

Exclusion Criteria:

• Any disease, condition or surgery which would result in a contraindication to undergoing FUS therapy.
• Clinical trials of pancreatic cancer not of focused ultrasound or related activities
• Other non-pancreatic cancer clinical trials

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Locations

Country	Name	City	State
Bulgaria	Medical University of Pleven	Pleven
Korea, Republic of	Seoul National University	Seoul
Taiwan	National Taiwan University Hospital	Taipei
United Kingdom	Oxford University Hospital	Headington	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
Focused Ultrasound Foundation	Navitas Clinical Research, Inc

Countries where clinical trial is conducted

Bulgaria,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Related to Pancreatic Cancer	The proportion achieving a 2 point reduction or greater will be assessed at each time point and across time using the Brief Pain Inventory (Short Form). Pain will be rated from 0 (no pain) to 10 (pain as a bad as can imagine) .	Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Other	Performance Status	Improvement in performance status for a period of at least 4 consecutive weeks without showing any sustained worsening.	Baseline, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Other	Clinical Benefit Response (CBR)	The proportion of participants with a CBR will be measured at each follow-up time point.	Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Other	Impact on Quality of Life and Cost	Standardized instrument to measure of health-related quality of life.	Baseline, Day 1, Day 7, Day 14, Day 30, Day 60, Day 90, Every 90 days thereafter through survival, up to 36 months
Primary	Survival	Time until the occurence of death	1 year